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Botulinum Toxin A for the Treatment of Keratoconus

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01691651
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Subcutaneous injection of botulinum toxin type A
  • Drug: Botulinum Toxin Type A
 N/A

Detailed Description

Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Botulinum Toxin Type A for Keratoconus
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Botulinum toxin type A

The group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.

Procedure: Subcutaneous injection of botulinum toxin type A
Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.

Drug: Botulinum Toxin Type A
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Other Names:
  • Botox (Allergan)

    		•
    No Intervention: Control

    The group that will not be subjected to any intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of the palpebral fissure [Eighteen months.]

      We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.

    Secondary Outcome Measures

    1. Corneal topography [Eighteen months.]

      We will evaluate corneal topography [flattest keratometry, steepest keratometry and average keratometry(unit of measure=diopters)]by 18 months.These time points will be included:baseline, 3, 6,12 and 18 months.

    Other Outcome Measures

    1. Corrected visual acuity [Eighteen months.]

      We will evaluate the corrected visual acuity (unit of measure=logMAR)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with documented keratoconus

    • best-corrected visual acuity measurable at refraction test

    • age between 10-40 years

    • good health

    • understand the procedure and its limitations

    Exclusion Criteria:

    • only one functional eye

    • previous ocular surgery

    • concurrent corneal infection and other ocular diseases that modified the visual acuity

    • known allergy to botulinum toxin

    • pregnancy

    • poor collaboration for performing the examinations and the procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of São Paulo, Department of Ophthalmology São Paulo Brazil 04023-062

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    • Principal Investigator: Adimara C Renesto, MD, Federal University of São Paulo
    • Study Chair: Teissy H Osaki, MD, Federal University of São Paulo
    • Study Chair: Midori H Osaki, MD, Federal University of São Paulo
    • Study Director: Mauro Q Campos, MD, Federal University of São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Adimara da Candelaria Renesto, MD, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT01691651
    Other Study ID Numbers:
    • RECUNIFESP-87051
    First Posted:
    Sep 25, 2012
    Last Update Posted:
    Oct 21, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Adimara da Candelaria Renesto, MD, Federal University of São Paulo
    Keratoconus
    Tetanus toxin
    Additional relevant MeSH terms:
    Keratoconus
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Oct 21, 2014